DUBLIN, Ireland, December 3, 2020 — Critical Path Institute, Ltd. (C-Path, Ltd.) announced today a new contract with the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU). The new project will leverage C-Path’s global expertise in developing novel product development tools.
“The mission of IMI, to improve health by speeding up the development of, and patient access to, innovative medicines, is carried out through collaborative projects, and each project has taken large steps forward towards reaching this goal,” said Pierre Meulien, IMI2 JU’s Executive Director. “IMI’s new contract with C-Path, Ltd. will identify opportunities to expand the impact of these projects for patients across Europe.”
Novel methodologies, including biomarkers, clinical outcome assessments and disease progression models, are tools that inform regulatory decision-making during the product development process. These tools can decrease clinical trial size and/or duration, inform endpoint selection, increase the patient voice, improve safety monitoring and more, depending on the tool. As a result, product developers have a more efficient process, bringing therapies to patients faster.
“C-Path’s expertise lies beyond leading collaborations that gather consensus among its member organizations,” said Acting Chief Executive of C-Path, Ltd. Graham Higson, M.Sc. “We’ve been uniquely successful in using these collaborations to identify key product development needs, assessing available data, then using that data to develop novel drug development tools.”
Often, these tools can be submitted for endorsement at the regulatory agencies, such as the European Medicines Agency. By doing so, product developers have increased confidence in the tool and are more likely to incorporate it into their development programs. Regulatory endorsed tools are also publicly available on agency websites.
Critical Path Institute, Ltd. (C-Path, Ltd.) is a wholly owned subsidiary of Critical Path Institute (C-Path), an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path, Ltd. EU is headquartered in Dublin, Ireland, and C-Path US is headquartered in Tucson, Arizona, with additional staff in multiple other locations. For more information, visit www.c-path.org and c-path.eu.